Abstract:
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The DIA-ASA Biopharm Safety Evaluation Working Group has developed a novel, open-source, interactive safety graphic tool to enhance the ability of safety professionals to identify and evaluate safety signals. The first tool released is designed to explore cases of potential drug-induced hepatotoxicity based on the eDISH plot developed by FDA. The tool allows the user to dynamically adjust laboratory thresholds to account for disease states with baseline elevated values, modify the time dimension for the occurrence of peak ALT/AST and bilirubin values, account for the extent of alkaline phosphatase elevation, with filters for demographic characteristics. Cases that appear in the potential Hy’s Law, Temple’s corollary and hyperbilirubinemia quadrants can be each be explored to detail the time course of changes in various analytes, assess the cholestatic or hepatocellular characteristics of the case and estimate the extent of hepatocyte loss. A workflow is provided to guide the user through the recommended analyses, using the features of the tool, for each of the quadrants of interest. The workflow is based on evaluations supported by expert hepatologists and the medical literature.
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